APIDRA PI PDF

PI & CMI Trade Names and Active Ingredients containing insulin glulisine. 1 Documents available. Need more information on a Apidra, CMIPI, Insulin glulisine. PI & CMI Trade Names and Active Ingredients containing insulin. 42 Documents Actrapid, PI, Insulin – human (human insulin) Apidra, CMIPI, Insulin glulisine. Apidra PI MKT. #v Page 1. PRODUCT INFORMATION. APIDRA APIDRA [insulin glulisine injection {rDNA origin}] is a recombinant human insulin .

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There is a theoretical concern that they could increase the risk of tumor development due to altered binding characteristics to insulin and insulin-like growth factor IGF -1 receptors caused by the structural changes made to the native insulin molecule. Apidra is supplied in New Zealand by:. Closely monitor blood glucose in all patients treated with insulin.

These studies have suggested that glulisine is safe, well tolerated, and is an effective option in the diabetes armamentarium. Quality of life No specific studies have addressed quality of life QoL in patients on glulisine. Apidra should be injected under the skin, being careful not to inject it into a muscle or vein.

Although the longest duration clinical study using CSII with glulisine did not show any increase in catheter occlusion rates compared with aspart, 19 in vitro studies suggest glulisine could theoretically be alidra liable to precipitate.

Comparison of insulin lispro with regular human insulin for the treatment of type 1 in adolescents.

Your doctor or diabetes educator aoidra show you how and when to do this. You may need to read it again. Once all the insulin is used, you cannot replace the cartridge. Tell your doctor if your diet changes. Tell your doctor if you often have hypoglycaemia or if you have ever become unconscious after using Apidra.

Health-related quality-of-life results from multinational clinical trials of insulin lispro: Do not take an extra dose apidrz a later time just because you have missed a dose. Metabolic memory is based on the concept that initial poor glycemic control during the diabetes disease course is associated with an increased risk of diabetes complications, despite optimal glycemic control later in the disease course and vice versa. You can do this by taking one of the following:.

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If you are experiencing low blood sugar levels hypoglycaemia – a “hypo”. Void where prohibited by law.

Comparative studies with the other rapid-acting insulin analogs are needed before the place of glulisine in the management of children and adolescents with type 1 diabetes can be better defined. Pregnancy may make managing your diabetes more difficult.

The baseline characteristics of these adult type 1 diabetes participants were similar between the two groups glulisine vs lispro.

One study, performed in adult patients, was a week multicenter, randomized trial that compared ppi efficacy and safety of glulisine versus aspart used in CSII in 59 patients with type I diabetes. Making Healthy Choices Cookbook. Table 4 Ongoing phase 4 studies of glulisine in children and adolescents.

Investigator Year of study Age Inclusion criteria Study design and aim Cemeroglu a — 4—11 years Prepubertal tanner stage I Type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis HbA 1c aidra.

Rapid and long-acting insulin analogues as an aproach to improve insulin therapy: In children no generalized hypersensitivity reactions have been reported, although there are few studies in this population. The pharmacokinetic and pharmacodynamic properties of glulisine appear to be similar in pediatric and adult patients. In solution, insulin molecules exist in equilibrium between monomers, dimers, tetramers, hexamers, and higher-order aggregates.

Introducing a simplified approach to insulin therapy in type 2 diabetes: Efficacy and safety of insulin glulisine versus insulin lispro as part of a basal bolus regimen in children and adolescents with type 1 diabetes.

New developments in the treatment of type 1 diabetes in children. Medicines that may reduce the blood sugar lowering effect of Apidra include:. Your dose of Apidra or other medicines may need to be changed.

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Fast-Acting, Mealtime Insulin | Apidra® (insulin glulisine [rDNA origin] injection)

If you need to put the syringe down, make sure the needle does not touch anything. Each country you visit will need to see this letter, so you should take several copies. There was one published pharmacokinetic study, 22 three review articles, 2324 and apidrz recent abstract 25 detailing the safety and efficacy of lispro versus glulisine.

On the basis of these studies, it is clear that further studies will be required before glulisine can be approved for use in CSII. If glucagon is used, have some sugary food or drink as soon apodra you are conscious again. This is because you could choke.

The role of insulin glulisine to improve glycemic control in children with diabetes mellitus

There are two Phase IV ongoing trials with glulisine in children and adolescents with type 1 diabetes. Pull the needle out of the Apidra vial. The other authors report no conflicts of interest in this work. If the product appears cloudy, discoloured or contains particles, or if the injection pen, cartridge or vial appears damaged.

The Diabetes Control and Complications Trial. Click here to learn more about Sanofi’s commitment to fighting counterfeit drugs. Make sure you keep enough Apidra to last over weekends and holidays. Certain heart medications, especially beta-blockers, may mask the symptoms of hypoglycaemia. Insulin and its analogs lower serum glucose levels by facilitating glucose uptake in skeletal muscle and fat, and by inhibiting gluconeogenesis, glycogenolysis, lipolysis, and proteolysis through its effect on the insulin receptor.

Few studies have compared the rapid-acting insulin analogs in this population but limited data indicate that glulisine is as effective as lispro when used in a basal—bolus regimen.

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